Minocycline to Treat Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring ALS, amyotrophic lateral sclerosis, minocycline
Eligibility Criteria
To be eligible for enrollment in this study, subjects must meet the following eligibility criteria within fourteen days prior to randomization: Inclusion criteria: A clinical diagnosis of laboratory-supported probable, probable or definite ALS, according to modified EL Escorial criteria. FVC greater or equal to 75% of predicted. Onset of weakness within 3 years prior to enrollment. If patients are receiving riluzole they must be on a stable dose for at least the past thirty days. Women of childbearing age must be non-lactating and surgically sterile or using an effective method of birth control and have a negative pregnancy test (adequate birth control includes use of intra-uterine device or oral contraceptives plus a barrier method, e.g. condom, diaphragm). Willing and able to give signed informed consent that has been approved by your Institutional Review Board (IRB). Exclusion criteria: Requirement for tracheotomy ventilation (or non-invasive ventilation > 23 hours/day). Diagnosis of other neurodegenerative diseases (Parkinson's disease, Alzheimer's disease, etc). FVC < 75% of predicted. A clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days. History of renal disease (screening creatinine greater than 1.5). History of liver disease (screening alanine aminotransferase greater than 3 times the upper limit of normal). History of hematologic disease (screening white blood cell count less than 3,800/mm3). History of system lupus erythematosis (or screening ANA of 1:160 or greater). Treatment with any medications that may cause lupus-like symptoms within 4 weeks of baseline visit (e.g. procainamide, hydralazine). History of vestibular disease (excluding benign position vertigo). Pregnancy or lactation. Allergy to tetracycline antibiotics. Use of minocycline within thirty days of enrollment (baseline visit). Use of anti-epileptic medications other than gabapentin. Limited mental capacity rendering the subject unable to provide written informed consent or comply with evaluation procedures. History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols. Use of any investigational drug within the past 30 days (Creatine, Vioxx, Celebrex, Topiramate). Women with the potential to become pregnant who are not practicing effective birth control.
Sites / Locations
- Mayo Clinic
- University of California, Irvine
- University of California Department of Neurology
- California Pacific Medical Center
- Univ. of Colorado Health Sciences Center
- Mayo Clinic
- University of Illinois
- Indiana University School of Medicine
- University of Iowa
- University of Kansas Medical Center
- University of Kentucky
- Hennepin County Med Center
- University of Minnesota
- Washington University
- UMDNJ/Robert Wood Johnson Medical Center
- University of New Mexico
- Columbia Unversity, Eleanor and Lou Gehrig MDA/ALS Center
- Carolinas Medical Center
- Duke University
- Wake Forest University
- Metro Health Clinic
- Oregon Health & Science University
- University of Pennsylvania
- Drexel University College of Medicine, Hahnemann Campus
- University of Texas Southwestern
- Methodist Hospital
- University of Texas Health Sciences Center
- University of Utah
- University of Vermont
- Virginia Mason Medical Center